Status:
COMPLETED
Safety of and Immune Response to a DNA HIV Vaccine (VRC-HIVDNA009-00-VP) in HIV Infected Individuals With Acute HIV Infection
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to evaluate whether the HIV vaccine VRC-HIVDNA009-00-VP will be safe in individuals who started antiretroviral therapy during acute HIV-1 infection. The study will also te...
Detailed Description
Highly active antiretroviral therapy (HAART) has greatly improved mortality and morbidity rates associated with HIV and AIDS. However, many HIV-1 infected individuals are unable to access HAART. It is...
Eligibility Criteria
Inclusion
- Treated acute HIV-1 infection (initiated HAART during the acute retroviral syndrome AND were diagnosed by a positive HIV-1 viral load and a negative or indeterminate Western blot)
- Minimum of 6 months of HAART, defined as 2 or more antiretroviral drugs in combination
- At least three CD4 cell counts over 350 cells/mm3 for a period of 6 months prior to study entry
- Screening CD4 cell count over 350 cells/mm3 within 30 days prior to study entry
- HIV-1 RNA levels over 50 copies/ml for a period of 6 months prior to study entry
- Screening HIV-1 RNA level less than 50 copies/ml within 30 days prior to study entry
- Agrees to use acceptable methods of contraception
Exclusion
- History of serious adverse reactions to vaccines
- History of CD4 cell count less than 250 cells/mm3, opportunistic infections, or AIDS-defining illnesses. Patients who have had one CD4 count less than 250 cells/mm3 or who have had CD4 counts less than 250 cells/mm3 for not more than 2 weeks during acute infection are not excluded.
- History of autoimmune disease, immunodeficiency, asthma, diabetes requiring insulin or oral hypoglycemics, thyroid disease, bleeding disorder, active malignancy, viral hepatitis, or asplenia
- Positive HBV, HCV, or syphilis test
- Suspected allergy or adverse reaction to any component of the study agent
- Changes in antiretroviral regimen within 6 months prior to entry due to virologic failure (not including toxicities)
- Previous participation in STIs
- Pregnancy or breast-feeding
- Live attenuated vaccines or investigational research agents within the 30 days prior to study entry
- Blood products within the 120 days prior to study entry
- Immunoglobulin within the 60 days prior to study entry
- Subunit or killed vaccines or allergy treatments with antigen injections within the 14 days prior to study entry
- Prior experimental HIV vaccines
- Certain immunosuppressive medications within the 6 months prior to study entry
- Current TB prophylaxis or therapy
- Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements
- Serious illness requiring systemic treatment and/or hospitalization. An individual who has either completed therapy OR is clinically stable for at least 14 days prior to study entry is eligible.
- Anti-dsDNA antibody greater than the upper limit of normal
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00125099
End Date
September 1 2007
Last Update
November 1 2021
Active Locations (5)
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1
Ucsd, Avrc Crs
San Diego, California, United States, 92103
2
Massachusetts General Hospital ACTG CRS
Boston, Massachusetts, United States, 02114
3
Brigham and Women's Hosp. ACTG CRS
Boston, Massachusetts, United States, 02115
4
Aaron Diamond AIDS Research Ctr. AIEDRP
New York, New York, United States, 10021